Refine by
Cleanroom Performance Articles & Analysis
6 news found
The official ISO 14644 cleanroom classification framework classifies cleanrooms by airborne particle concentration, while GMP projects require practical control of personnel flow, material flow, cleaning access, and environmental stability. ...
Selecting the right monitoring technique is pivotal in cleanroom contamination control. These specialized environments demand rigorous standards to ensure product integrity and safety. They are, after all, responsible for some of the most hygiene-critical applications on earth, from pharmaceutical manufacturing facilities to semiconductor fabrication plants. To minimize the risk of contamination ...
The newly published ISO 14644 part 21 provides clarification on the application of sound airborne particle sampling techniques in support of ISO 14644-1:2015 for classification of cleanrooms and clean zones, and ISO 14644-2:2015 for airborne particle monitoring, to provide evidence of cleanroom performance related to air cleanliness by particle ...
ISO 14644-2 Annex B states that “Statistical process control principles can be used to set alert and action levels based on analysis of historical data.” When performing a cleanroom certification, there is a specific formula to use for the contamination monitoring data to determine where to take the sample, in addition to sampling time and volume. ...
Introduction A cleanroom is a manufacturing or research environment that is purposely designed to have a very low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapours. ISO class cleanrooms (defined by ISO 14664-1) have a maximum allowable concentration for particles. ...
Several more quality standards have been included within the air velocity calibration services, now covering the requirements as set out in ISO 14644, GxP/GMP, DIN EN 12599, VDI 2083, VDI 2080, NEBB (1996) and IES-RP-CC006.2 our UKAS accredited air velocity calibration services will adhere to the specified requirements as laid out in the listed standards to ensure your compliance of your ...